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Toxins and Delivery in e-Cigarette Users (TADEUS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01714778
Recruitment Status : Completed
First Posted : October 26, 2012
Last Update Posted : March 13, 2014
Sponsor:
Information provided by (Responsible Party):
Queen Mary University of London

Tracking Information
First Submitted Date October 23, 2012
First Posted Date October 26, 2012
Last Update Posted Date March 13, 2014
Study Start Date February 2013
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 5, 2013)
Change in urinary 3HPMA levels after 4 weeks use of electronic cigarettes. [ Time Frame: 4 weeks ]
Change in urinary 3HPMA levels (a metabolite of acrolein) after 4 weeks use of electronic cigarettes, in both individuals who have stopped smoking conventional cigarettes and those who are still using them.
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT01714778 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: November 5, 2013)
  • Change in nicotine levels after 4 weeks use of electronic cigarettes (EC) [ Time Frame: 4 weeks ]
    Change in blood nicotine levels obtained from using an EC after 4 weeks use of electronic cigarettes (10 participants only).
  • Electronic cigarette acceptability [ Time Frame: 6 months ]
    Participants' views on electronic cigarettes
  • Use of electronic cigarettes [ Time Frame: 6 months ]
    Participants' use of electronic cigarettes
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Toxins and Delivery in e-Cigarette Users
Official Title Electronic Cigarettes: Potential Toxicant (Acrolein) and Nicotine Delivery in Users
Brief Summary

Electronic cigarettes or "e-cigarettes" (EC) may have a potential public health benefit as a safer alternative to smoking and possibly also as an aid in tobacco dependence treatment. However, there are concerns about their safety and whether they can deliver nicotine consistently and in doses necessary for such effects.

To be able to consider the safety of ECs and their potential in harm reduction, data are needed comparing the exposure to the potential toxicant, acrolein, in smokers of conventional cigarettes, users of EC, and people who use both products at the same time.

To accurately assess EC nicotine delivery, data are needed from people who use them regularly, as there is some evidence of higher and faster nicotine absorption in experienced users compared with naïve users who try them once in an artificial laboratory setting.

This study will provide information on both of these issues. Forty smokers will be given EC to use, in addition to behavioural support, as part of a stop smoking attempt. Levels of acrolein and nicotine will be measured before and after 4 weeks of EC use.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:

Urine is collected for analysis of a metabolite of acrolein (3-HPMA_.

Blood is collected for analysis of nicotine.

Sampling Method Non-Probability Sample
Study Population Smokers from the community who wish to stop smoking.
Condition Smoking Cessation
Intervention Other: e-Cigarette
Study Groups/Cohorts e-Cigarette
Smokers attempting to quit with behavioural support and e-Cigarettes.
Intervention: Other: e-Cigarette
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 5, 2013)
40
Original Enrollment Not Provided
Actual Study Completion Date January 2014
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Smokers who want help in quitting
  • Aged 18 or over

Exclusion Criteria:

  • Women who are pregnant or breastfeeding
  • People with any current serious illness
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT01714778
Other Study ID Numbers QMUL201208a
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Queen Mary University of London
Study Sponsor Queen Mary University of London
Collaborators Not Provided
Investigators Not Provided
PRS Account Queen Mary University of London
Verification Date March 2014